KR20000064408A - Nasal expander with low peel force - Google Patents

Abstract

The present invention relates to a nasal dilator 10 for separating outer wall tissue from internal structural tissue to expand nasal passages of a human nose. The dilator 10 is formed by a truss 16 having a pair of spaced apart end faces 20, 22, 46, the trusses providing restoring force upon exerting a force toward each other, the restoring force being multiple at each end. It is provided by elastic bands 30a, 30b having two grooves 43a, 43b, 43c and extending between opposing ends of the truss 16. The grooves 43a, 43b, 43c exceed the thickness of the bands 30a, 30b or more, and the separation portions 82, 82 ', 82 ", 82"', at predetermined positions of the elastic bands 30a, 30b, 82 " ", wherein the separators 82,82 ', 82 ", 82 "', 82 " " are surrounded by corresponding separator edges that cross the first surface of the first elastic band. . Second and similar bands may also be provided on the truss 16.

Description

Low nasal dilator

The present invention relates to a device for separating body tissue, and more particularly to a device for separating internal structural tissue and outer wall tissue to expand nasal passages of a human nose.

People often experience difficulty breathing due to internal obstructions. Examples of such disorders include septal detachment usually caused by nasal injury, swelling of internal nasal tissues due to allergic reactions, and nasal symptoms in patients with a common cold. The lower part of the nostril, ie just inside the nostril inlet, is known as non-table. The vision tablet narrows inward to a narrow bottleneck area called the nasal valve. The nasal passages widen again at the posterior part of the nasal passages. Nasal passages usually occur in the nasal passages where the nasal passages are substantially blocked. In general, in the case of the disorder, as the outer wall tissue is attracted during inhalation, the side wall of the nasal canal (i.e., partly the outer wall tissue relative to the nasal passage) stretches to almost or completely prevent the flow of air through the nasal passage.

Nasal congestion must be very annoying and bothersome for the person who suffers it. In particular, if oral breathing over a long period of time, if you breathe through the nose will cause lung irritation due to the introduction of foreign substances that would be filtered. Most people find it difficult to breathe at night because they have difficulty nasal breathing when sleeping. Nasal congestion can cause sleep disturbances, sleep irregularities or snoring, or both. In addition, people with these symptoms often wake up because they do not breathe enough oxygen.

When the cause of nasal obstruction is due to a structural problem such as a distal septum or a generally small tubular opening, and when the nasal obstruction seriously affects breathing, a common solution is to correct the nasopharyngeal malformation by surgery. Surgery, however, is expensive and may not ultimately solve the problem. An alternative commonly used to address allergies or disorders caused by a common cold is to spray the drug to reduce swelling of the tissue along the nasal passages. However, these therapies are often too insignificant to alleviate the above problems and may even damage tissues over long periods of use.

Because of the disadvantages arising from using the aforementioned methods, a method has been attempted to open the nasal passages using a mechanical aid named nasal dilator. Two such nasal dilators have been used, internal mechanisms that are effective in pushing the side of the nasal passages to open the nasal passages and external mechanisms that are effective in pulling part of the nasal passages. Internal instruments must be inserted into the nasal passages, which can cause itching to irritate the nasal passages. In addition, since each person's nasal cavity is different in shape, the nasal dilator must be specially designed for a particular user. An external nasal dilator is one that is firmly attached to the user's nose but is capable of adjusting the pulling force on the outer wall tissue, or that is detachably attached to the user's nose and provides a force to pull the wall tissue defined by the monolithic structure. Adjustable monolithic item. The former is difficult to remove and usually difficult to adjust to provide adequate force to fully expand the wall tissue without mechanical arrangements that allow it to be knocked obliquely during use and detachable.

The monolithic external nasal dilator is designed to provide sufficient force to distract without discomfort when pulling the tissue out, which can be placed relatively easily in a suitable location for use as an dilator and is also relatively easy to remove. This latter feature is achieved by an dilator using a spring loaded body with a pressure sensitive adhesive. As the skin moves under or near the dilator attached to the skin using the adhesive, it is caused by the end of a relatively rigid spring and the peel force (the force to peel) that separates the dilator from the skin along the proper geometry at the spring end. Is prevented. One method of using a spring member in the dilator body is to make the length of the spring member shorter than the length of the body in which they are received so that the position of the spring member in the body is centered, with each end of the spring member corresponding to the corresponding body end. To keep away from it. Such an example is disclosed in US Pat. No. 08 / 183,916 (B.C. Johnson, "Nasal Dilator", filed Jan. 19, 1994), which is incorporated herein by reference. In fact, a portion of the body end extending beyond the spring member acts as a body extension, suppressing the peeling force occurring at the ends of these spring members. However, this method requires a requirement to individually arrange the spring members during the manufacturing process, which leads to an increase in manufacturing cost and an error.

According to another conventional method, at the opposite end extending beyond the spring end, the central end portion of the dilator body is cut off during the manufacturing process so that its end edge touches the end of the short spring member or is not positioned shortly. More substantially, the spring is cut into units after having a length that extends the same length as the dilator body and is cut off as the central end portion is cut into units. This method has any spring member portions as disclosed in U.S. Patent No. 08 / 070,554 (WJ Dubec, DE Cohen and BC Johnson, filed "Nasal Dilator", filed April 20, 1993), which is incorporated herein by reference. Leaving the body lateral extension, which extends past the end of the spring member after the above-mentioned cut is made. However, although the nasal adherent extension used according to the geometry of the dilator end is disclosed in the document as suppressing peeling of the dilator from the skin, it rather limits the shape of the end that would have been available, and this extension also extends to the dilator body. Since it extends beyond the spring member, it results in an inevitable result that the material is somewhat wasted during the manufacturing process. This problem can be solved by removing any central end portion that is cut off and instead providing a relaxed safe cut between the spring member and the lateral extension. However, this arrangement may result in the part being peeled off rather than being cut off because the central end portions are present in their previous form. This slightly peeled off central end portion causes dirt to stick to the dilator in contact with the wearer's nose or in contact with the nose, causing itch and itch.

In addition, since there is an extension on the skin, evaporation is not good, and moisture is accumulated in the skin under the extension, and thus the structure is weakened at the location where the extension is present. When removing the dilator, the force present between the dilator extension and the skin changes from the main peel force to the main shear force, which is much larger in size due to the nature of the pressure sensitive adhesive used in the extension and thus from the skin. Skin weakened by greater shear forces during removal of the extension is likely to be damaged.

On the other hand, the omission of the extension or a loose cut between the spring member and the lateral side of the adjacent dilator leads the spring member to the end edge of the dilator. As the spring force is substantially constant along the dilator from one end edge to the other edge provided by the elastic member and the short portion of the back of the spring from these end edges has a relatively high stiffness, a considerable number of peeling forces of the dilator use So that the dilator end is separated from the user's skin. Peeling force is here a force that occurs because the skin under the dilator moves in normal use. Accordingly, there has been a desire for a monolithic dilator structure that can reduce the waste of material during manufacture, while reducing the risk of skin damage when detaching the dilator from the user's skin, regardless of the end of the dilator.

1 is a partial face view of a person with a dilator of the present invention attached to his nose.

FIG. 2A is an exploded view of the components of the present invention expander shown in FIG.

FIG. 2B is a partial fragmentary view of one of the components shown in FIG. 2A.

FIG. 3 is the same facial part view as FIG. 1 without using an dilator. FIG.

FIG. 4 is a cross-sectional view of the nose of FIG. 3 showing the nose with little air flow through the nasal passages. FIG.

FIG. 5 is a cross-sectional view similar to FIG. 4, showing the reduced air flow through the nasal passages.

FIG. 6 is a cross-sectional view of FIG. 1 showing a state in which a significant amount of air flow passes through the nasal passages.

7 is a diagram showing another embodiment of the present invention expander.

FIG. 8 is a partial view of the face with the dilator of FIG. 7 attached to the nose; FIG.

9 is a view of an expander of another embodiment of the present invention.

10 is a view of an expander of another embodiment of the present invention.

11 is a view of an expander of another embodiment of the present invention.

12 is a view of an expander of another embodiment of the present invention.

Fig. 13 is a partial view of the face with the dilator of Fig. 12 attached to the nose;

14 is a view of an expander of another embodiment of the present invention.

Figure 15 is an exploded view of an expander of another embodiment of the present invention.

Figure 16 is an exploded view of an dilator of another embodiment of the present invention.

Figure 17 is an exploded view of an expander of another embodiment of the present invention.

18 is an exploded view of an expander of another embodiment of the present invention.

Figure 19 is an exploded view of an dilator of another embodiment of the present invention.

20 is an exploded view of an expander of another embodiment of the present invention.

Figure 21 is an exploded view of an expander of another embodiment of the present invention.

Figure 22 is an exploded view of an expander of another embodiment of the present invention.

Detailed Description of the Preferred Embodiments

Specific expander 10 of the present invention is shown in FIG. The dilator 10 is used as a nasal dilator that is coupled to the nose 12 of a patient, shown as part of the human face 14.

Members used in the dilator 10 structure can be seen in the dilator exploded view shown in FIG. 2A. As shown in FIG. 2, the dilator 10 includes a single truss member 16, the truss member 16 being connected to the first end by a first end 20 and an intermediate portion 24. A base strip 18 having a second end 22 connected thereto. The width of the middle portion 24 is smaller than the width of the first end 20 and the second end 22 so that it covers less of the user's skin, thereby giving the user a comfortable feeling. Forming the base 18 with a polyester fabric is desirable in that the user's nose 12 skin exchanges with the atmosphere relatively easily to minimize irritation and provide maximum comfort during use of the dilator. Nonwoven spunlace 100% polyester fabrics suitable for forming the base 18 are described in E.I. It is SONTARA (registered trademark) sold by DuPont Nemours & Co. SONTARA® fabrics have a breaking strength characteristic of about 2: 1 when the breaking strength in the warp direction in the longitudinal direction (MD) to the weft direction in the transverse direction (XD) of the fabric is measured. In addition, SONTARA® fabrics have an elongation of about 3: 1 when measured for elongation for the same force in the transverse and longitudinal directions of the fabric. The longitudinal direction of the fabric is parallel to the longitudinal direction of the base material 18.

The truss 16 further comprises elastic means 26 attached to the first surface 28 of the base 18. The elastic means 26 has a first elastic band 30a and a second elastic band 30b. The first elastic band 30a has a first end 41a and a second end 42a. The second elastic band 30b has a first end 41b and a second end 42b. The first elastic band and the second elastic band 30a and 30b are each formed of a polymer material. For example, an industrial grade biaxially stretched polyester, such as MYLAR® Type A, obtained from EI DuPont Nemours & Co., having a width of about 0.080 inches to 0.135 inches and a thickness of about 0.010 inches. Cleaved) was found to be suitable.

Using relatively thin polymer materials as the first elastic band 30a and the second elastic band 30b, the axial torsional flexibility of each of these bands, depending on the width of the band actually used, is close to the magnitude of their respective longitudinal directions. Is increased.

The first elastic band 30a and the second elastic band 30b have three continuous grooves 43a, 43b and 43c, respectively. The groove 43a closest to the end of each of the first elastic band 30a and the second elastic band 30b is the deepest groove. For example, for an elastic band that is 2.60 inches long and 0.135 inches wide, the groove is typically at a position of 0.15 inches at the end of the elastic band inward, and is 80% to 100% of the thickness of the elastic band, typically 90 It has a depth of% to 100%. The next groove 43b inside the groove 43a is located 0.10 to 0.20 inches closer to the center and has a depth of 60% to 90%, typically 70%, of the elastic band thickness. Finally, the last groove 43c closest to the center of the elastic band is located 0.10 to 0.20 inches closer to the middle, but the depth is 40% to 70% of the thickness of the elastic band, typically about 40%.

Grooves may be further provided in series to extend closer to the middle portion of the elastic band, and the depths of the grooves may be different from each other. The effect obtained by introducing continuous grooves that are shallower toward the middle is that the effective spring constant decreases stepwise along the two half lengths of each of the bands starting at the middle of the elastic band. The deepest grooves reduce the effective spring constant to the maximum, so placing them at the band end is particularly effective in reducing the band spring force and the peel force at the ends of the elastic band resulting from the movement of the skin beneath it. Since the other remaining deeper grooves are towards the center of the band, the spring constant at each position of these grooves is lessened, increasing the effective spring constant towards the center along the direction of the elastic band end. As a result, the desired pull of the outer wall tissue of the user's nose is controlled by the type, length, thickness and width of the material, as described above, between the pressure sensitive adhesives below these band ends and the skin attached to the adhesive. Reduced enough to avoid inadequate peeling force.

The first elastic band 30a and the second elastic band 30b are connected to the first soluble strip 31a and the second flexible strip 31b of the interfacial adhesive on the first side 28 of the base strip 18. Are combined by. The first interfacial adhesive strip 31a has a first end 33a and a second end 34a. The second interfacial adhesive strip 31b has a first end 33b and a second end 34b. The first flexible strip 31a and the second flexible strip 31b of the interfacial adhesive have the same shape and size as the first elastic band 30a and the second elastic band 30b as shown in the drawing.

The first elastic band 30a is attached to the base strip 18 adjacent the first edge 32 of the middle portion 24 by an adhesive strip 31a. The second elastic band 30b is spaced in parallel with the first elastic band 30a and attached to the base strip 18 adjacent to the second edge 34 of the intermediate portion 24 by an adhesive strip 31b. do. The first elastic band 30a and the second elastic band 30b are oriented as described above, generally parallel to each other, and substantially parallel to the longitudinal direction of the base strip 18. Each of the interfacial adhesive strips 31a and 31b is an acrylic, pressure sensitive biocompatible transfer tape adhesive material (e.g., 3M 1509 available from Minnesota Mining and Manufacturing Company, Inc.) or acrylic, pressure sensitive biocompatible It is preferred that it is a transfer adhesive material (e.g., 1368B available from Vitam Co., Ltd. and Minnesota Mining and Manufacturing Company, 1524 available from Incorporated).

Truss 16 is a top surface of a flexible strip having a first end region 39, a second end region 40, and an intermediate portion 47 having the same size and shape as the base strip 18 shown in the figures. (38) is further provided. The lower surface 35 of the upper strip 38 includes an adhesive material layer 48, which is attached to the first end region 39 and the second end region 40 and the intermediate portion 47. Extend over. The adhesive material 48 is a porous acrylic pressure sensitive biocompatible adhesive. The top strip 38 covers the first elastic band 30a and the second elastic band 30b and the first surface 28 of the base strip 18 and is attached thereon by an adhesive layer 48. .

In the case where the truss are bent by skin movement under the truss 16, the top strip 38 is formed from the first elastic band 30a and the first strip from the base strip 18 and the interfacial adhesive strips 31a and 31b. 2 prevents the elastic band 30b from being separated. In addition, the top strip 38 provides some degree of the base strip 18 by providing a more rigid material in their main plane to provide a more geometrically stable combination to facilitate installation and removal of the dilator 10. Restrict. The top strip 38 is preferably a porous nonwoven material having an adhesive 48 provided thereon (eg, Minnesota Mining and Manufacturing Company, 3M 1533 available from Incorporated).

Looking further with respect to the base strip 18 of FIG. 2, the second face 44 has an adhesive layer 46 thereon, the adhesive layer having a first end region and a second end region 20 and 22. It extends over the middle part 24. Adhesive 46 is a porous acrylic pressure sensitive biocompatible adhesive. Adhesive 46 is used to attach the dilator 10 to the skin of the outer wall tissue of the nose 12 in which the dilator is used. Fabrics suitable for forming the base strip 18 are available with adhesive 46 provided thereon, such as 3M 1776, available from Minnesota Mining and Manufacturing Company, Inc., Incorporated.

The adhesive 46 is covered with a pair of release liners with a first release liner 49 and a second release liner 50 before use. These release liners cover the adhesive 46 in the first end region 20 and the second end region 22 of the base strip 18 and the extensions 51 of the first release liner 49. ) And the extension 52 of the second release liner 50 cover the adhesive 46 at the intermediate portion 24 of the base strip 18. The first release liner 49 and the second release liner 50 are easily removed from the adhesive 46.

As shown in FIGS. 3 and 4, the human nose 12 extends between the first nasal passage 54, the second nasal passage 56, and the first nasal passage 54 and the second nasal passage 56. And a portion of the nose 12 referred to as a snorkel 58 located outward. Figure 4 shows the state of the nasal passages in the respiratory cycle when there is little air flow through the nasal passages, and shows the nasal passages of a person without diseases related to the nasal passage and the nasal passage. Thus, nasal passages 54 and 56 are relatively open and air is easy to pass through.

At the apex of inspiration during the breathing process, the internal pressure of the nose is slightly reduced so that the outer wall of the nose is slightly attracted. However, if there is a nasal injury that causes nasal obstruction, or if there is a swelling of the airway lining tissue because of an allergic reaction or illness, the outer wall forming tissue on the outer side of each of the first pore 54 and the second nostril 56 60 and 62 lower the air pressure significantly than increase the air velocity through the narrowed airway because the respirator attempts to breathe more during inspiration. The outer wall tissues 60 and 62 then tend to pull the nasal passages more strongly, as shown in Figure 5, and sometimes even collapse to an extent that the airway is almost obstructed. A portion of the outer wall tissue 60 and 62 drawn during inspiration is located between the end of the nasal bone and fibula and the inlet of the nasal passage 54 and 56 as shown by the dashed lines in FIGS. 1 and 3. As a result, nasal congestion occurs when the outer wall tissues 60 and 62 are attracted. The extent of this stuffy nose depends on how narrow your pessimism is. Nasal dilator 10 is provided as a treatment to solve this nasal congestion problem.

When using the nasal dilator 10, the dilator removes the first release liner 49 and the second release liner 50 to expose the adhesive 46 and then uses it to form the outer wall tissue 60 of the nose 12. And 62) attach the dilator to the skin of the stomach. As shown in FIGS. 1 and 6, the nasal dilator 10 includes a first end region 20 and a second end region 22 with an intermediate portion 24 crossing the nose 58 of the nose 12. The adhesive 46 was attached to the outer shell of the nose 12 so as to contact the outer wall tissue 60 and 62 of the first nasal passage 54 and the second nasal passage 56, respectively. By means of the first end region 20 and the second end region 22 of the dilator 10 and the adhesive 46 located in the intermediate portion 24, the monolithic truss member 16 is the outer wall of the nose 12. Adheres to tissues 60 and 62 and groin 58.

Attaching the nasal dilator 10 in the proper position of the nose 12 causes both ends of the first elastic band 30a and the second elastic band 30b to be resilient to tend to return to a flat state toward each other. The outer wall tissues 60 and 62 are pulled out. The position of these outer wall tissues 60 and 62 is stabilized by countering the suction forces acting on the outer wall tissues 60 and 62 when inhaling this pulling force. Flexibility of the base material 18, the interfacial adhesives 31a and 31b, and the upper surface material 38, and the resilience of the first elastic band and the second elastic band 30a and 30b (these indicate that the thickness is relatively thin). Flexibility) all fit the nasal dilator 10 to the nose curves of the individual wearer to provide comfort during use. In addition, the relatively thin elastic bands 30a and 30b improve the axial torsional flexibility with respect to the longitudinal elongation of the truss member 16, thereby increasing the wearer's comfort and the adhesion of the adhesive 46 to the wearer's nose. Help to preserve adhesion.

In addition, the fabric strip of the spunlace fabric structure provided as the base strip 18 is mainly plastic, but is limited to have a certain elasticity, it is possible to deform within the thickness range of the base 18. This deformation property spreads through strip delamination force. This delamination force is (1) the inherent tendency to return to the normal planar state of the elastic bands 30a and 30b, (2) the difference in surface structure between the elastic band and the wearer's nose 12, and (3) the wearer's The outer wall tissues 60 and 62 are applied to the outer wall tissues of the nose and the shear, tension, separation or peeling forces applied to the truss member 16 due to skin movement (e.g., nose movement) or contact with external objects such as pillows. This occurs because of the displacement of the single truss member 16 relative to the unitary body. This delamination force tends to inadvertently separate the nasal dilator 10 from the wearer's nose 12. Dispersing the delamination force, the base strip 18 acts as a mechanical buffer that prevents concentrated forces from being transmitted to the adhesive 46 and to the wearer's nose 12 skin. When the delamination force is concentrated on the skin of the nose 12, the adhesive 46 is detached from the skin portion below the dilator 10 so that the wearer 14 feels itchy, but by transferring the concentrated delamination force. The phenomenon is substantially eliminated.

The range of forces pulled outwardly provided to the outer wall tissues 60 and 62 by the expansion force provided by the dilator 10, i.e. the resilience of the elastic bands 30a and 30b of the truss member 16, ranges from 5 g to 50 g or more was found to be suitable. If the dilatation force was 10 g or less, it was usually insufficient for most wearers with severe nasal congestion. However, if the symptoms of nasal congestion are not so severe, the wearer may obtain a positive effect even if the dilation force provided by the dilator 10 is as small as 5 g. If the dilator's expanding force exceeds 40 g, most, if not all, of the wearer feels somewhat uncomfortable.

Thus, the nasal dilator 10 is typically 20-30 g on the outer walls 60 and 62 of the nasal passages 54 and 56 at least in the inner positions of the grooves 43a, 43b and 43c of the elastic bands 30a and 30b. It is manufactured to provide spring expansion force. Each of these elastic bands provides a portion of the overall value. The spring expanding force in the grooves at the end of the dilator 10 is gradually reduced as described above to reduce the peeling force occurring at the end of the dilator 10. The two elastic bands 30a and 30b used in the monolithic truss member 16 are generally the same size, are similarly located and have grooves 43a, 43b and 43c of constant size, so that the band ( 30a and 30b) each provide about ½ of the total spring expansion force occurring at each location along the length of the dilator 10, but may vary in width and length to vary the expansion force along the length of the nose.

As shown in Figs. 1 and 6, the single truss member 16 includes a base strip 18, interfacial adhesive strips 31a and 31b, a top surface 38 and a first elastic band 30a and a second one. An elastic band 30b, one end of the truss member having a first sectoral edge 70a and the other end having a second sectoral edge 70b. The first fan-shaped edge 70a has a first end region 20 of the base strip 18 and a first end region 39 of the upper face 38 and a first end 41a of the elastic bands 30a and 30b. And 41b) and the first ends 33a and 33b of the adhesive strips 31a and 31b. The second scalloped edge 70b is the second end region 22 of the base strip 18 and the second end region 40 of the upper face 38 and the second end 42a of the elastic bands 30a and 30b. And 42b) and second ends 34a and 34b of adhesive strips 31a and 31b. Since the first fan-shaped edge and the second fan-shaped edge 70a and 70b are similar, only one of them can be understood to explain both, and only the first fan-shaped edge 70a will be described herein.

The first sectoral edge 70a has two projections 72a and 74a that are divided by a setback point 76a. The degree of protrusion of the protrusions 72a and 74a is determined by the cutting die used to form the dilator 10 from a continuous strip of materials that matched the materials to the truss member 16 and formed into the dilator 10. The protrusion at is selected as the first ends 41a and 41b of the elastic bands 30a and 30b respectively corresponding to the first ends 33a and 33b of the adhesive strips 31a and 31b. Since the protrusion of the elastic band is the outermost line, no elastic band material is wasted in die cutting the truss member 16 in the continuous strip. Since the protrusion of the elastic band in one truss member 16 fits snugly with the protrusion of the next truss member 16, there is substantially no need to cut the material between them, so there is no loss in the manufacturing process. Due to the material on the side of one of each side and the reinforcement 76a from the protrusion included in the elastic band and the outer line of the elastic band, the material is slightly lost when cutting between adjacent truss member portions, respectively. Will be. However, this material loss was greatly reduced, and the loss of elastic band material was almost eliminated. Therefore, economic efficiency can be greatly improved in the manufacturing process using the continuous elastic band extending to the end of the expander.

Therefore, the expander can be manufactured without unnecessary waste in the continuous production work. However, the dilators of the illustrated design are not inadvertently peeled off at their ends during use. That is, due to facial movements, forces acting on external factors such as pillows during bedtime, the dilator does not delaminate the end region from the wearer's nose skin. This is because the spring constant is greatly reduced for each of the opposing ends of the dilator, which occurs because there are grooves 43a, 43b and 43c towards the distal ends of the elastic bands 30a and 30b provided in the dilator. Therefore, the expander is provided by an efficient manufacturing process that can adjust the spring constant to a predetermined value at various positions along the length of the expander.

As shown in Fig. 2, the elastic bands 30a and 30b are attached to the base strip 18 using adhesive strips 31a and 31b before the grooves 43a, 43b and 43c are cut into elastic strips. In this case, the base strip 18 retains any part of the elastic bands 30a and 30b by the attachment in a relatively identical position, and the incision of the grooves continues as long as the separation points of these elastic bands form another one. Should be. This is also the case when the cutting action must cut the portion of the base strip 18 below the groove because the strip material extends outwardly from one side of the elastic strip. In the case of attaching the elastic bands 30a and 30b before cutting the groove, this retention action is supplemented by the surface strip 38 so that the groove incision is made through the top face, which is one of these elastic bands. This is because the strip extends beyond.

However, additional costs are added to fabricating the dilator by providing the base strip 18 and the top strip 38 to the dilator 10. These costs can be achieved by using a material that forms a monolithic structure with an acrylic pressure sensitive biocompatible adhesive attached to one side of a porous (required if a small hole is drilled in the band to aid evaporation of moisture, otherwise unnecessary). 10) is a cost that can be avoided when fabricating only with elastic band material. The adhesive provides an attachment means for attaching the dilator obtained to the wearer's nose and assists in dispersing a delamination force that may inadvertently detach the dilator from the wearer's nose 12. However, the dispersion of the delamination force by the adhesive is insufficient unless a groove formed in the elastic material forming the dilator is provided.

One possible groove arrangement that preserves the rest of the dilator or the end of the elastic band even though the groove extends throughout the dilator forms a groove in the band such that it does not reach one of the faces of the elastic material band forming the body of the dilator. will be. Thus, this arrangement leaves a part between the corresponding sides of the band on the side of the groove between the ends. Of course, the band material remaining between the groove and each side of the band exhibits a significantly reduced spring constant, reducing the outward force present at the corresponding end of the dilator, resulting in the end of the dilator peeling off the wearer's skin. Is lowered. However, the remaining band material is still retained in the band portion between each of the dilator and the dilator end portion grooves and the corresponding opposite end edge, so there is no need for a base strip or a face strip, even if the groove is cut completely through the band.

In other words, the band material remaining between the groove and the side of the band or dilator is retained at the end of the band beyond the groove and bends very well to reduce the peel force at the end edge, which converts the peel force into shear force through this bending. And the shear force is better suppressed by an adhesive that attaches the dilator to the skin of the wearer's nose. The grooves in the elastic band of the dilator are normally cut simultaneously in the band itself, and die cutting of the elastic material makes a small amount of material remaining between each groove and the side of the band. The bands and grooves are cut from the adhesive covering the band face to the opposite side so that the groove sidewalls and the adhesive covering the surface of the band meet at an obtuse angle and do not produce sharp edges placed on the wearer's skin, even if the other cut is made. Get

The groove may be simply cut into the band in the form of a "V" just before or just before the slit incision in the band, but instead of extending entirely throughout the band, a very wide groove may be used, the width of which is narrower than the width of the band. That is, as shown in the lower surface of the dilator shown in Figure 7 may have a groove-shaped groove extending in the band. The dilator 10 (indicated by the dots in FIG. 7) is formed of a single elastic band strip 80 having a porous acrylic pressure sensitive biobonding adhesive 81, which adhesive is formed on its underside during use on the wearer's nose. Where it is coated. Elastic band 80 is formed of the same elastomeric material (industrial grade biaxially oriented polyester as described above, such as MYLAR® Type A) as used in bands 30a and 30b, and the width of the band Is about 0.375 inches in the middle of the narrowest part of the band, slightly wider at the end past the middle, and perhaps slightly increased in order to maintain the same effective spring constant as the width is increased.

The pair of elongated openings 82, or holes, are provided with a wide groove that forms an effective separation between the adhesive 81 and the same portion of the band 80 through the elastic band 80, the elongated openings It is not elongated to reach the side and is located at the opposite end edge of the band. Although the opening appears to completely pass through the band and completely separate the enclosed inner portion of the band from the rest of the band, the opening 82 need not extend in the entire direction of the band 80. Although predominantly extending throughout the band 80, the preliminary filling holes 82 can be placed in place without having to remove them. Whatever they are, the opening 82 substantially separates the remaining central portion of the band 80 and its end portion on the opposite surface of the opening 82. In addition, the elastic band 80 may be drilled into a number of small openings over a significant area, or throughout the band (not shown) to help evaporate moisture under the band.

The material portion 83 remaining between the end of the opening 82 and the side of the band 80 has an end portion 84, each near the opposite end playing of the corresponding opening 82 and the band 80. Located in The end portion 84 by the material portion 83 will be preserved even if the opening 82 completely passes through the band 80. Residual material portion 83 allows the end portion 84 to bend relatively easily compared to the center portion of the band 80, so that these end portions are along the contour of the side of the user's nose without significant outward forces occurring at the ends. To be attached. This arrangement effectively converts the large peel force at the outer ends of these end portions 84 into shear forces that are greatly suppressed by the adhesive 81.

FIG. 8 shows the dilator 10 of FIG. 7 disposed in the nose portion 12 of the face 14 of the person, and the dilator is usually disposed at the same position as the dilator described above. The homogeneous monolithic dilators shown in Figures 7 and 8 have only one opening 82, each of which is located near the opposite end of the strip 80 to reduce the effective spring constant at that location to oppose the strip. Provides reduced outward force at the end. Alternatively, a series of openings, or wide grooves, may each be provided near the opposite end of the strip 80 to reduce the effective spring constant at that location, with the opening extending longer along the length of the strip to lessen the change. Can be done. This reduction in spring constant dispersion can be achieved by selecting a series of openings to vary the length of material leaving some material between the end of the opening and the side of the band. Thus, of the series of openings, the opening 82 closest to the center of the band 80 is the shortest and the openings toward the end of the band 80 are longer so that an effective reduction of the spring constant is at the maximum value towards the center of the band. It becomes smaller toward the bottom.

The openings 82 or grooves shown in Figs. 9, 10 and 11 are manufactured in various modifications to reduce the spring constant, which do not limit the openings 82 of Figs. . Thus, in FIG. 9, the dilator 10 provides a groove through an opening or incision that is different from that shown in FIGS. 7 and 8, wherein the opening is symmetrically round rather than an elongated opening, or a rectangular rounded end. Hole 82 '.

10 and 11 show a pair of cut slit into the grooves rather than a wide opening as a substantial separation forming grooves between the central and end portions of the dilator 10. FIG. 10 shows a pair of slit openings 82 ", which slit openings leave the interior of the circular portion attached to the rest of the band 80 along the side closest to the center of the band. It has a circular portion (but not an elliptical or other closed curve) of more than one half of the circular end portion of 82 '. The slit opening 82 "has its end spaced from the side of the band 80 so that the side of the band In order to minimize the possibility of crack transfer from the end of the slit is continued past half of the circular part.

Alternatively, the straight slit in FIG. 11 is a substantial separation that cuts the band 80, but each end thereof has a small circular opening to provide a pair of openings 82 '", which circular slit Prevents the growth of cracks from the end of the band 80 to the side of the band 80. Such crack growth usually occurs during die cutting of these openings into the dilator 10 rather than occurs during use, because each of the dilators is merely This is because the bending of the remaining material portion 83 is repeated relatively little since it is used only once.

In addition, grooves or broader openings can be used to increase the flexibility in the longitudinal and transverse directions of the elastic band 80, as shown in the dilator 10 of FIGS. 7, 9, 10 and 11. Likewise, flexibility in the longitudinal direction and the width direction of each of the opposite ends of the elastic band 80 is also provided. Thus, FIG. 12 shows a longitudinal opening 85 as well as a pair of elongated openings 82 that substantially separate the end region 84 from the central remainder of the elastic band 80, such as the dilator 10 of FIG. ), The longitudinal opening intersects with the opening 82 and extends beyond the opening 82 to almost reach the length of the dilator 10 and thus the side portion of the band 80. Substantially separate.

As a result, the residual material portion 86 is provided between the ends of the longitudinal opening 85 and the opposite end edge of the corresponding dilator 10. The presence of a longitudinal opening 85 that extends almost to the opposite end edge of the dilator 10 results in two side portions, that is, the longitudinal subbands 87, in which the remaining material portions 86 are formed. Bends relatively easily with respect to one another in order to increase the widthwise flexibility of the elastic band 80. In fact, the subband 87 is almost similar to the function of the elastic bands 30a and 30b in the dilator 10 of FIG. Further, the bottom view of the dilator 10 is shown in FIG. 12 to expose the adhesive 81 indicated by the points present on the elastic band 80 in the end region 84 and the subband 87.

FIG. 13 is a view showing a state in which the dilator 10 of FIG. 12 is attached to the nose 12 of the face 14 of a person. In FIG. 12, the dilator 10 is placed in the nose 12 position where the dilator described above is used.

In order to further improve the flexibility of crossing the width of the dilator 10, a longitudinal opening parallel to the elastic band 80 can be further used as shown in the dilator 10 of FIG. This case is shown in FIG. 14, where the dilator of FIG. 14 has a pair of parallel longitudinal openings 85 'resulting in three subbands 87' in the elastic band 80, and in the longitudinal direction. Each of the openings 85 'intersects all of the corresponding pairs of lateral openings 82' ". As a result, two small residual material portions between the sides of the dilator 10 and the openings 82 '". 83 is provided, and a smaller material portion 83 'is formed between the two openings 82' "at each end of the dilator 10. Similarly, at each end of the longitudinal opening 85 ', There are two residual material portions 86 ′ between the opposite end edges of the dilator 10.

The dilator 10 of FIGS. 12 and 13 can be manufactured very similarly to the dilator described above by providing a base strip below, and is attached to an elastic band 80, such as the band 80 form shown in FIG. And the strip has adhesive for attaching to the user's nose rather than to the elastic band 80. Likewise, the top strip may be supplied over the elastic band 80 and attached thereon with or without the base strip.

An exploded view of this arrangement is shown in FIG. 15, using the form of elastic band 80 shown in FIG. 12, to remove the adhesive 81 located thereon and instead attach the dilator to the wearer's nose 12. The bottom face of the base strip 18 'was used. An elastic band 80 is attached to the base strip 18 'and the structure has a top strip 38' so that they are now attached to form a homogeneous monolithic dilator rather than homogeneous. Base strip 18 ′ may be formed of the same material as described in base strip 18 of dilator 10 of FIG. 2, and top strip 38 ′ is top surface of dilator 10 of FIG. 2. It can be formed of the same material as the ash strip. The same type of adhesive used in the dilator 10 of FIG. 2 may be used to attach the elastic band 80 to the base strip 18 ′ and the top strip 38 ′ to unite the parts. Usually, a porous acrylic pressure sensitive biocompatible adhesive can be used as a coating method, or an acrylic pressure sensitive biocompatible transfer adhesive can be used.

Alternatively, the dilator 10 of FIG. 12 having an adhesive 81 on the bottom surface of the dilator may be described above when the top strip 38 'is attached to the elastic band 80 in the arrangement shown in exploded view of FIG. Can be used as is. Likewise, the elastic band 80 can be attached to the lower strip 18 'without using the upper strip 38'. In addition, the same kind of adhesive used in the dilator 10 of FIG. 2 can be used to make the parts unitary. The dilator structures of FIGS. 15 and 16 extend beyond the end edge of the band beyond the dimensions of the top strip 38 'or elastic band 80 extending to the dimensions of the outer edge of the elastic band 80. FIG. Or strips beyond the sides of the band, or both. The dilator structure of FIG. 15 is likewise a strip or band extending beyond the end edge of the band beyond the dimensions of the lower strip 18 'or elastic band 80 extending to the dimensions of the outer edge of the elastic band 80. FIG. Strips over the sides of or both may be used.

The arrangement of the expanders 10 of FIGS. 7, 9, 10 and 11 in a similar arrangement where the advantage of using the lower strip to disperse the delamination force and to stabilize the top strip is desirable with respect to the use of the elastic band 80. Can be provided as 17 and 18 illustrate the use of the elastic band 80 of FIG. 7, wherein the adhesive 81 is moved from the elastic band 80 to the bottom of the lower strip 18 'to the wearer's nose. Attach to In the exploded view of these figures, a strip having an opening 82 at the opposite end of the elastic strip 80 is provided and attached between the lower strip 18 'and the upper strip 38'. In FIG. 17, the lower strip 18 'and the top strip 38' are dimensioned with the elastic band 80, but these strips are larger than the dimensions of the elastic band 80 in the structure shown in FIG.

In addition, the dilator 10 shown in FIGS. 7, 9, 10 and 11 may be formed from the base material from the structures shown in FIGS. 17 and 18 for any form of elastic band 80 used in these structures as described above. By omitting the use of the strip 18 ′, an adhesive 81 can be used on the bottom surface to adhere to the wearer's nose. This leaves only the top strip 38 'attached to the elastic band 80, an example of this arrangement is shown in FIGS. 19 and 20 using the elastic band 80 of FIG. 19 shows a top strip 38 'having the same dimensions as the outline edges of the elastic band 80, and FIG. 20 shows a top piece having both a length and a width larger than the outline dimension of the elastic band 80. FIG. The strip 38 'is shown.

Although the top strip 38 'may be omitted in the structures shown in Figures 17 and 18, the elastic bands of Figures 7, 9, 10 and 11 used in these structures, using the lower strip 18'. At 80, the adhesive 81 can be moved to the bottom of the base strip 18 ′ and attached to the wearer's nose. 21 and 22 are exploded views of this arrangement. 21 and 22, the elastic band 80 of FIG. 7 is used, and the elastic band 80 is attached to the lower strip 18 ', and the adhesive on the skin on the opposite surface of the lower strip is attached. exist. The lower strip 18 'shown in Figure 21 has the same dimensions as the elastic band 80, while the lower strip 18' shown in Figure 22 exceeds both the length and width dimensions of the elastic band 80. do. The same type of adhesive used in the dilator 10 of FIG. 2 may be used to unite the components used in the structures of FIGS. 17-22.

Although the present invention has been described with reference to preferred embodiments, modifications and variations are possible without departing from the scope and spirit of the invention.

Summary of the Invention

The present invention provides an expander in which the tissues are fastened so that they are spaced apart from each other when a force is applied to the wall tissues of the human body in use. The dilator of the present invention includes a truss having a pair of spaced end faces that provide restoring force that separates the end faces as they are forced toward each other. The end face is fitted with a joining means which sufficiently engages the exposed surfaces of the outer wall tissues and remains engaged against restoring forces. This restoring force is provided in part by at least a first elastic band having a predetermined thickness extending between the edges of opposing ends of the truss, ie adjacent the end face. Here, the elastic band allows a plurality of notches disposed therein to be disposed over the band so as to have a restoring force at a location where the groove is located. The groove may have a separator at a position between selected portions of the first elastic band, which is surrounded by corresponding separator edges around the intersection with the first surface of the first elastic band. These grooves can be divided into two groups near the opposite end edges of the elastic bands in the truss, with the deepest and largest grooves adjoining the ends and the other grooves progressively less and deeper towards the center of the truss. The second elastic band is provided inside the truss so as to be completely or mostly spaced apart from the first elastic band and extends between its end edges, while containing a groove therein.

Claims (12)

A truss having a pair of spaced end surfaces terminated by end edges at opposite ends of the truss, means for generating restoring force and means for reducing the restoring force, the restoring force generating means being a truss extending between the end edges; The first elastic band having at least one predetermined thickness therein and the spacing between them is substantially reduced by an external force that reduces the spacing of the trusses when the spacing end faces are forced towards each other at an initial position. The restoring force tends to recover a gap between the end faces, the restoring force being generated by at least the first elastic band; The means for reducing restoring force comprises a separating portion at a predetermined position between selected portions of the first elastic band, the separating portion being surrounded by a corresponding separating edge around the intersection with at least the first surface of the first elastic band. With truss to lose, Attachment means designed to adhere to the exposed surface of the outer wall tissue and to remain adhered against the restoring force, the attachment means attached to the end surface Expander for separating the stress in the anatomical outer wall tissue, characterized in that it comprises a. 2. The anatomical outer wall tissue according to claim 1, wherein the separation part has a corresponding separation edge of a periphery intersecting at least a part of the second surface of the first elastic band on a surface opposite the position where the first surface occurs. Expander for separating stresses in the The method of claim 1, wherein the first elastic band is joined at its first end by between the end edges and two side edges at which the separation occurs, such that the portion of the separation edge is closest to the separation edge. An dilator for separating stress in anatomical outer wall tissue parallel to each of the lateral ends. The anatomical outer wall tissue of claim 1, wherein the truss has a flexible cover strip and the first elastic band is located at least in part between the flexible cover strip and any exposed surface of the attached outer wall. Expander to isolate stress. The anatomical outer wall tissue of claim 1, wherein the truss has a flexible base strip that is located at least in part between the first elastic band and any exposed surface of the attached outer wall. Expander to make it work. 2. The dilator of claim 1, wherein said first elastic band is a molded sheet of at least partially perforated polymeric material. 2. The separator according to claim 1, wherein the separating edge has two longitudinal portions extending substantially parallel to each other along the longitudinal direction, wherein the longitudinal portion is between end edges of the truss and crosses the longitudinal direction. An dilator for separating stress in an anatomical outer wall tissue that is connected to a lateral edge of the separation edge at each of the opposing ends extending in a direction. The method of claim 1, wherein a plurality of separation portions are present at a predetermined position of the first elastic band between predetermined portions of the separation portion, each of which is surrounded by a corresponding separation edge crossing at least the first surface. Dilator for separating stress in anatomical outer wall tissue. The anatomical outer wall tissue of claim 2, wherein the separating edge has portions spaced apart from each other throughout the separating portion to cause the separating portion to form at least a portion as an opening in the first elastic band. Expander to make it work. 3. The anatomical outer wall tissue of claim 2, wherein the separating edge has portions that adjoin each other throughout the separating portion to cause the separating portion to form at least a portion as a slit in the first elastic band. Expander to separate. 4. The separator according to claim 3, wherein a plurality of separators are present at a predetermined position of the first elastic band between predetermined portions of the separators, each separator being surrounded by corresponding separator edges intersecting at least the first surface. The first elastic band is joined to the opposite end by two remaining lateral ends between the remaining end edge and the plurality of separating edges, so that the corresponding portion of the separating edge is most closely aligned with the separating edge. An dilator for separating stress in anatomical outer wall tissue that is in parallel with each of said two additional lateral edges. 8. A separator according to claim 7, wherein a plurality of separators are present at a predetermined position of the first elastic band between predetermined portions of the separator, each separator being surrounded by corresponding separator edges intersecting at least the first surface, Each of the plurality of separation edges has two longitudinal portions extending substantially parallel to each other along the longitudinal direction, the longitudinal portions being between end edges of the truss and extending in the cross direction of the longitudinal direction. An dilator for separating stress in the anatomical outer wall tissue that is connected to the transverse edge of the separator edge at each of the opposing ends that are formed.